PSV · Class II · 21 CFR 892.1550

FDA Product Code PSV: Ultrasound Bronchoscope

An Ultrasound Bronchoscope Is Indicated For The Ultrasonic Visualization, Diagnosis And Therapeutic Access To The Bronchial Tree Or The Lungs. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).

Leading manufacturers include Olympus Medical Systems Corp..

3
Total
3
Cleared
122d
Avg days
2002
Since